(252 days)
No
The device description and performance studies focus on the physical properties and mechanical performance of the ureteral stents. There is no mention of AI or ML in the intended use, device description, or performance testing sections.
Yes.
The device is intended for "drainage of the upper urinary tract over fistulas or ureteral obstacles and/or for healing of the ureter," which describes a therapeutic purpose.
No
This device is a ureteral stent, which is used for drainage and healing of the urinary tract, not for diagnosing medical conditions.
No
The device description clearly states it is a physical, implantable device made of silicone, provided with a pusher and in some cases a guidewire. It undergoes mechanical/performance testing and sterilization, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a silicone double loop ureteral stent. Its intended use is for the drainage of the upper urinary tract and/or healing of the ureter. It is an implantable device that physically interacts with the body's internal structures.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens outside of the body. Its function is entirely within the body.
Therefore, this device falls under the category of a medical device (specifically, an implantable surgical device), but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
ImaJin® Silicone double loop ureteral stent kits, ImaJin® Pyelostent® Silicone double loop ureteral stent kits, ImaJin® Stenostent® Silicone double loop ureteral stent kits
Indications for Use (Describe)
Silicone double loop ureteral stents:
The Silicone double loop ureteral stents are intended for adult and pediatric (children and adolescents) patients for drainage of the upper urinary tract over fistulas or ureteral obstacles and/or for healing of the ureter. These stents may remain implanted for up to 12 months.
Pyelostent and Stenostent Silicone double loop ureteral stents: Drainage of the upper urinary tract and/or ureter healing during management of ureteral stenosis:
For Pyelostent® Silicone double loop ureteral stents:
Partial enlargement of the stent diameter, for localized stenosis of the ureteropelvic junction in adult and pediatric (adolescents) patients.
For Stenostent® Silicone double loop ureteral stents: Total enlargement of the stent diameter, for ureteral stenosis in adult and pediatric (children and adolescents) patients.
The Pyelostent® and Stenostent® Silicone double loop ureteral sterts may remain implanted for up to 12 months.
Product codes
FAD
Device Description
The ImaJin Silicone double loop ureteral stent kit product family was originally cleared as Porges™ Silicone Double Loop Ureteral Stents in 510(k) K013921. The ImaJin Silicone double loop ureteral stent family consists of three single use, autostatic stents intended to drain the upper urinary tract and allow healing in case of ureteral obstacles or damage to the ureter. The Pyelostent and Stenostent Silicone double loop ureteral stents have partial and complete reinforcement along the straight catheter section respectively to add crush resistance. The devices are provided with a pusher and in some cases a guidewire. The Silicone double loop ureteral stents are ethylene oxide sterilized, single use, implantable devices.
The current submission is to update the indication for use statement, revise the Instructions for Use, add information on MRI compatibility, modify drainage hole size in some models, modify packaging, and modify the device performance specifications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper urinary tract, ureter, ureteropelvic junction
Indicated Patient Age Range
adult and pediatric (children and adolescents) patients, adult and pediatric (adolescents) patients, adult and pediatric (children and adolescents) patients.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance data was provided for the proposed changes and to support the substantial equivalence determination.
Mechanical/Performance Testing
- Visual Evaluation
- Dimensional Testing
- Shaft Diameter and Length
- Guidewire and Pusher Compatibility
- Liquid Compatibility
- Flowrate per EN 1618:1997
- Glide on Guidewire (Friction)
- Tensile Strength Testing per EN 1618:1997
- Elongation
- Loop Strength
- Radiopacity
- Shelf Life/Expiration date
- MRI Safety Testing
- Package Integrity Testing
- Transportation Testing
Sterilization
The Imajin Silicone double loop ureteral stent kits. ImaJin Pyelostent Silicone double loop ureteral stent kits, and ImaJin Stenostent Silicone double loop ureteral stent kits are sterilized using ethylene oxide in a validated cycle in conformance with ISO 11135-2014, demonstrating a sterility assurance level (SAL) of 10-6.
No animal studies or clinical testing were provided to support substantial equivalence between the subject and predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Porges™ Silicone Double Loop Ureteral Stents, K013921
Reference Device(s)
Silicone Hydro-coated double loop ureteral stent, K180469
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.4620 Ureteral stent.
(a)
Identification. A ureteral stent is a tube-like implanted device that is inserted into the ureter to provide ureteral rigidity and allow the passage of urine. The device may have finger-like protrusions or hooked ends to keep the tube in place. It is used in the treatment of ureteral injuries and ureteral obstruction.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 8, 2022
Coloplast Corp. Gayatri Ghadge Principal Regulatory Affairs Specialist 1601 West River Road North Minneapolis, MN 55411
Re: K213185
Trade/Device Name: ImaJin® Silicone double loop ureteral stent kits, ImaJin® Pyelostent® Silicone double loop ureteral stent kits, ImaJin® Stenostent® Silicone double loop ureteral stent kits
Regulation Number: 21 CFR§ 876.4620 Regulation Name: Ureteral Stent Regulatory Class: II Product Code: FAD Dated: May 6, 2022 Received: May 9, 2022
Dear Gayatri Ghadge:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
1
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products): good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Jessica K. Nguven, Ph.D. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K213185
Device Name
ImaJin® Silicone double loop ureteral stent kits Imalin® Pyelostent® Silicone double loop ureteral stent kits. ImaJin® Stenostent® Silicone double loop ureteral stent kits
Indications for Use (Describe)
Silicone double loop ureteral stents:
The Silicone double loop ureteral stents are intended for adult and pediatric (children and adolescents) patients for drainage of the upper urinary tract over fistulas or ureteral obstacles and/or for healing of the ureter. These stents may remain implanted for up to 12 months.
Pyelostent and Stenostent Silicone double loop ureteral stents: Drainage of the upper urinary tract and/or ureter healing during management of ureteral stenosis:
For Pyelostent® Silicone double loop ureteral stents:
Partial enlargement of the stent diameter, for localized stenosis of the ureteropelvic junction in adult and pediatric (adolescents) patients.
For Stenostent® Silicone double loop ureteral stents: Total enlargement of the stent diameter, for ureteral stenosis in adult and pediatric (children and adolescents) patients.
The Pyelostent® and Stenostent® Silicone double loop ureteral sterts may remain implanted for up to 12 months.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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ર. 510(k) SUMMARY
| I. SUBMITTER
| 510(K) Owner's Name: | Coloplast A/S |
|---|---|
| Address: | Holtedam 1 |
| 3050 Humlebaek, Denmark | |
| Phone/Fax/Email: | Phone: 612-422-3206 |
| Email: usggh@coloplast.com | |
| Name of Contact Person: | Gayatri Ghadge |
| Principal Regulatory Affairs Specialist | |
| Address/Contact: | 1601 West River Road North |
| Minneapolis, MN 55411 | |
| Date Prepared: | June 7, 2022 |
| II. DEVICE | |
| Device Name: | Imajin® Silicone double loop ureteral stent kits |
| ImaJin® Pyelostent® Silicone double loop ureteral stent kits | |
| ImaJin® Stenostent® Silicone double loop ureteral stent kits | |
| Common or Usual Name: | Double Loop Ureteral Stents |
| Classification Name: | |
| Classification Number: | |
| Product Code: | |
| Regulatory Class: | Stent, Ureteral |
| 21 CFR section 876.4620 | |
| FAD | |
| 2 |
III. PREDICATE AND REFERENCE DEVICES
| Predicate Device: | Porges™ Silicone Double Loop Ureteral Stents, K013921 |
|---|---|
| Reference Device: | Silicone Hydro-coated double loop ureteral stent, K180469 |
The predicate and reference devices have not been subject to a design-related recall.
IV. DEVICE DESCRIPTION
The ImaJin Silicone double loop ureteral stent kit product family was originally cleared as Porges™ Silicone Double Loop Ureteral Stents in 510(k) K013921. The ImaJin Silicone double loop ureteral stent family consists of three single use, autostatic stents intended to drain the upper urinary tract and allow healing in case of ureteral obstacles or damage to the ureter. The Pyelostent and Stenostent Silicone double loop ureteral stents have partial and complete reinforcement along the straight catheter section respectively to add crush resistance. The devices are provided with a
4
pusher and in some cases a guidewire. The Silicone double loop ureteral stents are ethylene oxide sterilized, single use, implantable devices.
The current submission is to update the indication for use statement, revise the Instructions for Use, add information on MRI compatibility, modify drainage hole size in some models, modify packaging, and modify the device performance specifications.
V. INDICATIONS FOR USE
Silicone double loop ureteral stents:
The Silicone double loop ureteral stents are intended for adult and pediatric (children and adolescents) patients for drainage of the upper urinary tract over fistulas or ureteral obstacles and/or for healing of the ureter. These stents may remain implanted for up to 12 months.
Pyelostent and Stenostent Silicone double loop ureteral stents: Drainage of the upper urinary tract and/or ureter healing during management of ureteral stenosis:
For Pyelostent® Silicone double loop ureteral stents: Partial enlargement of the stent diameter, for localized stenosis of the ureteropelvic junction in adult and pediatric (adolescents) patients.
For Stenostent® Silicone double loop ureteral stents: Total enlargement of the stent diameter, for ureteral stenosis in adult and pediatric (children and adolescents) patients.
The Pyelostent® and Stenostent® Silicone double loop ureteral stents may remain implanted for up to 12 months.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Imajin® Silicone double loop ureteral stent kits, ImaJin® Pyelostent® silicone double loop ureteral stent kits, and ImaJin® Stenostent® silicone double loop ureteral stent kits are currently cleared for the US market under the predicate 510(k) Porges™ Silicone Double Loop Ureteral Stents, K013921. The proposed changes to the previously cleared devices do not alter the performance or intended use of the products. The Imalin Silicone double loop ureteral stent family has equivalent design, function, packaging, sterilization process, material technology, indications for use and operating principles as the predicate device. The differences in indications for use, contraindications, MRI compatibility, packaging, and performance specifications do not significantly alter the device compared to the primary predicate. The modified performance specifications are the same as for the reference device, Silicone Hydro-coated double loop ureteral stent, K180469.
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K213185 Page 3 of 3
VII. PERFORMANCE DATA
The following performance data was provided for the proposed changes and to support the substantial equivalence determination.
Mechanical/Performance Testing
- Visual Evaluation ●
- Dimensional Testing
- o Shaft Diameter and Length
- Guidewire and Pusher Compatibility ●
- Liquid Compatibility
- Flowrate per EN 1618:1997
- Glide on Guidewire (Friction)
- Tensile Strength Testing per EN 1618:1997
- Elongation
- Loop Strength
- Radiopacity
- Shelf Life/Expiration date
- MRI Safety Testing ●
- Package Integrity Testing ●
- Transportation Testing ●
Sterilization
The Imajin Silicone double loop ureteral stent kits. ImaJin Pyelostent Silicone double loop ureteral stent kits, and ImaJin Stenostent Silicone double loop ureteral stent kits are sterilized using ethylene oxide in a validated cycle in conformance with ISO 11135-2014, demonstrating a sterility assurance level (SAL) of 10-6.
No animal studies or clinical testing were provided to support substantial equivalence between the subject and predicate devices.
VIII. CONCLUSIONS
Based upon the intended use, technological characteristics, and non-clinical performance data provided, the Imajin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone double loop ureteral stent kits, and ImaJin Stenostent Silicone double loop ureteral stent kits have been demonstrated to be substantially equivalent to the predicate, Porges™M Silicone Double Loop Ureteral Stents, cleared under premarket notification number K013921. The changes do not raise new questions of safety or effectiveness and the subject devices are as safe and effective as the predicate device.